This study aimed to explore the efficacy and safety of cyclosporine (CsA) +eltrombopag (EPAG)/hetrombopag (HPAG)+romiplostim N01 in the treatment of newly-diagnosed transfusion-dependent aplastic anemia (TD-NSAA) and severe aplastic anemia (SAA)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
CsA 3-5mg/kg/d, trough concentration 100-200ng/ml
Eltrombopag 50mg/d, increased by 25mg every two weeks Hetrombopag 7.5mg/d, increased by 2.5mg every two weeks
Romiplostim N01 20µg/kg, subcutaneously, once a week
Overall response rate (ORR)
ORR=CRR+PRR
Time frame: 6-month
ORR
ORR=PRR+CRR
Time frame: 3-month, 12-month
red blood cell (RBC)/platelet (PLT) transfusion independent rate
Proportion of patients who achieve red blood cell (RBC)/platelet (PLT) transfusion independence for 8 weeks or longer
Time frame: 3-month, 6-month, 12-month
AE rate
proportion of patients with adverse events, according to CTCAE
Time frame: through study completion, an average of 1 year
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